Associate Director, Drug Product External Manufacturing Quality Assurance - Bristol Myers Squibb
Summit, NJ
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Associate Director, Drug Product External Manufacturing QA provides Quality oversight to Contract Manufacturing Organizations (CMOs) production and disposition. This role will partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T/CTTO), Analytical Science & Technology (AS&T) and Supply Chain (SC) teams to provide QA oversight of CMO(s) including Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition to support the clinical and commercial release of Drug Product. This role will also develop and manage the collaboration and governance relationship with CMOs during technology transfer and routine operations and ensure CMO(s) remains compliant to regulatory requirement and BMS procedures.
Shift Available:
+ Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.
Responsibilities:
+ Provide QA oversight during CMO on-boarding process including Technology Transfer studies, data auditing, review/approval of protocol/reports, and inspection readiness activities such as GMP assessment, mock/regulatory PLIs, and system remediations.
+ Responsible for quality approval on CMO manufacturing batch record, investigations, CAPA, change control records, and disposition
+ Participate in the vendor Health Authority inspections and provide support as the BMS representative
+ Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits
+ Establish Quality Agreement with CMOs and ensure compliance, and oversee trending of key quality, product and GMP metrics
+ Provide guidance and governance to cross functional internal and CMO teams on quality compliance and GMP requirements for CMO manufacturing
+ Participate in Material Review Board meetings and evaluate recommendations made by the board
+ Ensure the Annual Product Review reflect the operations performed by CMOs, provide the appropriate level of detail and required trend analysis
+ Identify gaps at the assigned CMOs and provide pragmatic solutions aligned with business needs
+ Champion a culture of agility and continuous improvement
+ Mentor and enable development of direct and indirect reports
+ Other Quality responsibilities may be assigned
Knowledge & Skills:
+ Expertise in GMP, Quality, and risk management
+ Ability to interpret problems, scientific based decision making and effectively prepare communication in a productive manner to management and cross functional teams with clarity, brevity, and accuracy
+ Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
+ Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross- functionally
+ Knowledge of required quality processes for clinical/commercial materials and expectations for international markets
+ Detail-oriented with demonstrated applications in problem solving and decision-making abilities
+ Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, building relationships, and resource allocation
+ Team player and leader who can work independently to achieve objectives in a fast-paced environment
+ Ability to travel up to 2 0 % (Domestic and International)
Basic Requirements:
+ Bachelor's or Master's degree in biochemistry, cell biology, microbiology, chemistry, engineering, or related fields.
+ At least 10 years of experience in biopharmaceutical quality, with a minimum of 4 years in progressively responsible management roles.
+ In-depth knowledge of applicable FDA/EMA regulations in the biotechnology industry.
+ Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, though relevant Quality experience will also be considered.
+ Prior experience in launching or implementing commercial manufacturing in a GMP facility, including PAI approvals, EMPQ, and APS.
+ Experience with QA oversight of drug product manufacturing, cellular therapeutics/gene-based products, and/or biologics products is preferred.
+ Strong project management skills.
+ Excellent communication, troubleshooting, and problem-solving abilities.
BMSCART, #LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1587784
Updated: 2025-01-31 03:16:25.345 UTC
Location: Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Associate Director, Drug Product External Manufacturing QA provides Quality oversight to Contract Manufacturing Organizations (CMOs) production and disposition. This role will partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T/CTTO), Analytical Science & Technology (AS&T) and Supply Chain (SC) teams to provide QA oversight of CMO(s) including Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition to support the clinical and commercial release of Drug Product. This role will also develop and manage the collaboration and governance relationship with CMOs during technology transfer and routine operations and ensure CMO(s) remains compliant to regulatory requirement and BMS procedures.
Shift Available:
+ Monday - Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.
Responsibilities:
+ Provide QA oversight during CMO on-boarding process including Technology Transfer studies, data auditing, review/approval of protocol/reports, and inspection readiness activities such as GMP assessment, mock/regulatory PLIs, and system remediations.
+ Responsible for quality approval on CMO manufacturing batch record, investigations, CAPA, change control records, and disposition
+ Participate in the vendor Health Authority inspections and provide support as the BMS representative
+ Collaborate with Quality Systems and ensure CMO's timely implementation of corrective actions resulted from BMS's audits
+ Establish Quality Agreement with CMOs and ensure compliance, and oversee trending of key quality, product and GMP metrics
+ Provide guidance and governance to cross functional internal and CMO teams on quality compliance and GMP requirements for CMO manufacturing
+ Participate in Material Review Board meetings and evaluate recommendations made by the board
+ Ensure the Annual Product Review reflect the operations performed by CMOs, provide the appropriate level of detail and required trend analysis
+ Identify gaps at the assigned CMOs and provide pragmatic solutions aligned with business needs
+ Champion a culture of agility and continuous improvement
+ Mentor and enable development of direct and indirect reports
+ Other Quality responsibilities may be assigned
Knowledge & Skills:
+ Expertise in GMP, Quality, and risk management
+ Ability to interpret problems, scientific based decision making and effectively prepare communication in a productive manner to management and cross functional teams with clarity, brevity, and accuracy
+ Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
+ Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross- functionally
+ Knowledge of required quality processes for clinical/commercial materials and expectations for international markets
+ Detail-oriented with demonstrated applications in problem solving and decision-making abilities
+ Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, building relationships, and resource allocation
+ Team player and leader who can work independently to achieve objectives in a fast-paced environment
+ Ability to travel up to 2 0 % (Domestic and International)
Basic Requirements:
+ Bachelor's or Master's degree in biochemistry, cell biology, microbiology, chemistry, engineering, or related fields.
+ At least 10 years of experience in biopharmaceutical quality, with a minimum of 4 years in progressively responsible management roles.
+ In-depth knowledge of applicable FDA/EMA regulations in the biotechnology industry.
+ Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, though relevant Quality experience will also be considered.
+ Prior experience in launching or implementing commercial manufacturing in a GMP facility, including PAI approvals, EMPQ, and APS.
+ Experience with QA oversight of drug product manufacturing, cellular therapeutics/gene-based products, and/or biologics products is preferred.
+ Strong project management skills.
+ Excellent communication, troubleshooting, and problem-solving abilities.
BMSCART, #LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1587784
Updated: 2025-01-31 03:16:25.345 UTC
Location: Summit West-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb